Data processing: generic control systems or specific application – Specific application – apparatus or process – Article handling
Reexamination Certificate
2001-10-12
2003-02-18
Tran, Khoi H. (Department: 3651)
Data processing: generic control systems or specific application
Specific application, apparatus or process
Article handling
C700S216000, C700S244000, C053S052000, C053S053000, C053S055000, C053S493000
Reexamination Certificate
active
06522945
ABSTRACT:
TECHNICAL FIELD
This invention relates to an automated packaging line for assembly line filling of different orders for different quantities of different products, in different lot sizes, for specific customers, and more particularly to a system and process for simultaneous packaging on a single production line of orders for different quantities of different medications for intermediate customers and for ultimate users of the medications.
BACKGROUND ART
Prior art systems have been proposed to fill tablet containers automatically. However, many containers are still manually filled at the pharmacy level based upon a given prescription. While the manual method of filling may provide an accurate and high quality prescription drug filled container, it is tedious, time consuming and expensive.
Moreover, packaging systems presently used at the manufacturer level are inflexible and incapable of filling individual orders, because of a lack in the prior art of any process or apparatus for communication of order specific information to various stations on a drug packaging line, for example. Thus, known tablet packing systems indeed pack only one tablet type at a time, using only one bottle size, providing only one count of tablets per bottle and applying only one type of pre-printed label to the bottle. Changeover of such lines to provide a new product, bottle or label thus takes from two to eight hours, losing a significant amount of production time. Because of such significant time losses, present manufacturing and packaging operations require very substantial quantities of a product (a minimum of 50,000 to 100,000 packages) to be packed in a particular format before changeover, with the consequential requirement for storage of large inventories in warehouses for progressive distribution. Thus, distribution of pharmaceutical products requires intermediate wholesalers who, in turn, supply specific retailers or pharmacies.
Thus, existing systems require holding of large inventories of packaged products at a number of points along a supply chain, resulting in time delays on the order of six months from manufacture of a table to dispensing of that tablet to a customer. Product expiration thus becomes of concern because of the existing methods of packaging tablets and the like.
Archer et al. U.S. Pat. No. 5,522,512 discloses an automatic system for continuously filling tablet containers, which is capable of automatically feeding, inspecting and diverting tablets based upon a predetermined set of parameters to provide a filled tablet container having the proper number and type of tablets therein. The device and method disclosed therein is particularly capable of sorting a continuous stream of tablets to automatically fill a container with a predetermined number of tablets such as prescription pills, for direct distribution. In the case of pharmaceuticals, the filled container is suitable for distribution to the user or wholesaler.
Charhut et al. U.S. Pat. No. 5,208,762 similarly attempts to reduce pharmacist involvement in prescription filling. However, the system disclosed therein is intended to operate at the retail pharmacy level, being only capable of filling about 1100 vials in a day. The system of the '762 patent requires a plurality of lines respectively provided for filling vials of different sizes. Each line includes an unscrambler for incoming vials and a modified Automatic Tablet Control (ATC) machine as a vial filler, and permits use of a plurality of such ATC machines in each line depending on drug mix and drug volume required by the institution. A known labeler and a known capper operate on the filled vials and an accumulator sorts and ejects vials having an improper drug count, unreadable labels or improperly seated caps.
However, in the '762 system data flow relating to the patient (i.e., consumer, or customer) order information, and to the status of the order at any stage in the process, as well as to the various safety checks implemented therein, is maintained and controlled by a central control system. Such an approach is extremely limiting of the line processing speed and capacity, as a single control unit must keep track of each of a large number of operational steps for each of the vials being processed. There is no provision for autonomous control of various line operations at the individual stations and components of the line, as all order information is centrally maintained and processed.
The contents of the above described prior art, including particularly the Archer et al. U.S. Pat. No. 5,522,512, are hereby incorporated by reference.
The above described art, however, fails to provide a fully automated system, operating at mass-production level of manufature, which is capable of filling individual customer orders as well as intermediate and wholesale level orders, with a capability of providing individually printed labels for each individual order and each individual bottle, where a single bottle may form an entire order, and with fill quality assurance at each step of the manufacturing process. Indeed, the described art is not capable of eliminating requirements for intermediate storage of the packaged tablets, or other products, at a warehouse level.
The inventors have thus discovered a deficiency in the prior art with respect to a failure to provide assembly line filling of individual customer orders, as well as of intermediate and wholesale level orders, at a mass-production level of processing which has the capability to provide individually printed labels for each individual order whether it comprises a plurality of bottles or a single bottle, with full quality assurance at each step of the manufacturing process. Indeed, the described art does not eliminate requirements for intermediate storage of the packaged tablets, or other products, at a warehouse level and thus requires a complex product distribution system, from manufacturer to storage to shipping for distribution to intermediate storage to wholesaler (and storage) to dispenser (and storage) and only finally to the direct consumer.
DISCLOSURE OF THE INVENTION
It is accordingly an object of the present invention to overcome the deficiencies of the prior art and to provide a customer specific packaging line operating at a mass production level, for filling a plurality of different orders for different quantities of different tablets or other products in one run, for properly and individually labeling the filled orders and for providing full quality control and assurance at each step of the process prior to shipping the filled orders directly to the ordering customer, thereby to provide a complete and automated packaging-to-shipping system for packaging different orders on a single line and for shipping the packaged orders to the customer.
It is a more specific object of the invention to provide a customer specific packaging line allowing individual and multiple specific orders to be processed simultaneously, on a mass production, assembly line basis.
It is another and still more particular object of the invention to provide such a customer specific packaging line for simultaneously filling, in a single process, a plurality of different prescriptions, for different quantities of different medications for different consumers and intermediate customers.
It is yet another object of the invention to improve efficiency by reducing expenses, time and facilities necessary to provide medications to a consumer by replacing existing packaging-to-inventory-to-shipping operations with a packaging-to-shipping operation.
Another object of the invention is to provide such a customer specific packaging line for simultaneously filling different prescription bottles with a plurality of different prescriptions, for different quantities of different medications for different consumers and intermediate customers, and to provide for assembly line preparation and affixation, to the corresponding prescription bottles, of proper labels, respectively corresponding to and identifying the different prescriptions contained
Bargh Adrian Neil
Kennedy Michael
Owen Stephen
Proudfoot Andrew H.
Sleep Nicholas J.
McDermott & Will & Emery
Merck & Company, Inc.
Tran Khoi H.
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